Publications by authors named "Tymara Berry"
Most cancers and neoplastic progenitor cells have elevated telomerase activity and preservation of telomeres that promote cellular immortality, making telomerase a rational target for the treatment of cancer. Imetelstat is a first-in-class, 13-mer oligonucleotide that binds with high affinity to the template region of the RNA component of human telomerase and acts as a competitive inhibitor of human telomerase enzymatic activity. Pharmacokinetics, pharmacodynamics, exposure-response analyses, efficacy, and safety of imetelstat have been evaluated in vitro, in vivo, and clinically in solid tumor and hematologic malignancies, including lower-risk myelodysplastic syndromes (LR-MDS) and myeloproliferative neoplasms.
View Article and Find Full Text PDFPopulation pharmacokinetics of imetelstat, a first-in-class oligonucleotide telomerase inhibitor.
CPT Pharmacometrics Syst Pharmacol
July 2024
Article Synopsis
- * A mixed-effects model was created to analyze how different factors like demographics and health conditions affect the drug's pharmacokinetics using data from 424 patients across seven clinical trials.
- * The final model found that factors such as sex, disease type, and dosage impact drug clearance and volume in the body, but generally suggests that body-weight-based dosing is appropriate without needing individual dose adjustments for most patients.
Article Synopsis
- The study focuses on patients with lower-risk myelodysplastic syndromes (LR-MDS) who depend on red blood cell transfusions and are either not responding to current treatments or are ineligible for them, particularly erythropoiesis-stimulating agents (ESAs).
- It involves a phase 3 clinical trial comparing the effectiveness of imetelstat (a telomerase inhibitor) to a placebo in achieving red blood cell transfusion independence, involving 178 participants across various countries.
- The primary goal was to measure the percentage of patients who went at least 8 weeks without needing transfusions after starting treatment, with results from this study expected to provide insights into a potential new treatment
Article Synopsis
- * The phase III trial, IMpactMF, will compare imetelstat to the best available therapies (excluding JAK inhibitors) in these refractory MF patients.
- * The trial will administer imetelstat via IV every 21 days, focusing on overall survival as the main goal, while also examining additional effects such as symptom relief, spleen size, and safety.
Fedratinib is an oral, selective Janus kinase 2 (JAK2) inhibitor. The phase II JAKARTA2 study assessed fedratinib in patients with intermediate- or high-risk myelofibrosis (MF) who were resistant or intolerant to prior ruxolitinib per investigator assessment. Patients received fedratinib 400 mg/day in 28-day cycles.
View Article and Find Full Text PDFThe phase 4 ABOUND.70+ trial assessed the safety and efficacy of -paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line -paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same -paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d).
View Article and Find Full Text PDFIntroduction: The phase II ABOUND.PS2 study (NCT02289456) assessed safety/tolerability of a first-line modified -paclitaxel/carboplatin regimen for patients with advanced non-small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.
Methods: Chemotherapy-naive patients with stage IIIB/IV NSCLC and ECOG PS 2 received four cycles of -paclitaxel 100 mg/m days 1 and 8 plus carboplatin area under the curve 5 day 1 q3w (induction).